BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF VALSARTAN IN RABBIT PLASMA

Sandhya Pamu *, C. V. S. Subrahmanyam and K. S. K. Rao Patnaik

Objective: To develop a liquid–liquid extraction based reversed-phase high performance liquid chromatography method for estimation of valsartan in rabbit plasma. Methods: Chromatographic separation was carried out using ODS Thermosil C18 (250mm×4.6mm) 5μm, with mobile phase composed of ammonium acetate buffer (20mM) and acetonitrile in 60:40 v/v ratio, pH 6.5. The analyte was monitored with UV detector at 265nm. The developed method was validated with respect to specificity, linearity, accuracy, precision, LOD, LOQ and ruggedness. Results: The peak area ratio of valsartan to that of internal standard was used for the quantification of samples. The flow rate was 1.0 ml/min and the eluent was monitored at 265 nm. Calibration curves were linear in the concentration range of 10-200 ng/mL. The LOD and LOQ of present method were found to be 1.8 ng/mL and 5.4 ng/mL respectively. Extraction recoveries of drug from rabbit plasma were found to be >90 %. Conclusion: A simple, specific, reproducible and sensitive RP-HPLC method was developed and validated for the estimation of valsartan in rabbit plasma.